Provide process engineering expertise for process design, process scale-up, trouble-shooting and process efficiency improvements. Interrogate laboratory working directions to determine optimum plant configuration to ensure that the process [chemistry + plant] meets the scale-up objectives in a safe manner. Support capital projects for R&D Jurong.
Key Responsibilities
Lead process engineering activities for NCE projects in the pilot plant
- Review of chemistry scale-up requests with Chemists, Operations and Engineering to determine optimum plant configuration.
- Define detailed plant and modification design. The time period for introducing new chemistry onto plant is usually less than 4 weeks, during which time any new equipment requirements must be identified, designed, fabricated, installed [by on-site staff or contractors], commissioned, tested and operating staff trained in use before chemical processing starts.
- Agree level of hazard assessment with Operations and complete Process Risk Assessment.
- Review batch record, carry out installation checks, write WI [Work Instruction] or SOP [Standard Operating Procedure] as required and train operators.
- Support campaign on plant, troubleshooting any engineering issues.
Technology Transfers
- Generate sufficient process engineering information for GSC to ensure that the process can be effectively introduced into the desired production plant.
- Support synthetic organic chemists, process safety scientists, and process chemists in the design of processes suitable for effective scale-up.
- Assess critical process characteristics and requirements as well as existing plant capabilities and limitations by gathering and interpreting suitable experimental data.
- Significantly contribute to the development of robust manufacturing processes for the synthesis of bulk drug substance by evaluating alternative processing strategies and recommending potential process improvements.
- As a member of the ChemDev project team, identify and effectively communicate the best suitable scale-up strategy for a process including recommendations for the application of new processing technologies.
- Play an important role in facilitating a seamless technology transfer of processes to GSC by the application of state-of -the-art tools and procedures.
Capital Projects
- Act as client representative for capital projects, to ensure all the customer needs are incorporated into the design and installation of new plant and equipment.
- Identify areas of weakness in the portfolio of processing technologies (plant and equipment) and submit proposals to address these.
- Define and seek approval for the detailed project scope of plant and equipment projects, and obtain approval for capital orders and PIP's.
- Review and make recommendations on design proposals put forward by contractors, project engineers, and equipment suppliers.
- Organise HAZOP studies, act as technical recorder, and issue HAZOP report for all installations where appropriate.
- Issue commissioning programmes, lead commissioning activities, and issue final reports.
- Carry out pre-delivery inspection visits for new equipment, prior to acceptance on site.
- Compile equipment WIs.
Knowledge, Skills & Experience
- Min A level certification
- Experience in pharmaceutical industry
- Experience in pharmaceutical process
- In depth working knowledge of the safety and compliance requirements for equipment and systems used in it.
- Strong written and verbal communication skills.
- Ability to multi-task and prioritize workload
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